Category
Ophthalmic Drugs Recalls
490 ophthalmic drugs recalls on record from CPSC, FDA, and USDA.
490 recalls
High RiskFDA
Thea Pharma, Inc.
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Wal...
Ophthalmic Drugs0 affectedApr 23, 2026
High RiskFDA
Thea Pharma, Inc.
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02...
Ophthalmic Drugs0 affectedApr 23, 2026
High RiskFDA
Preferred Pharmaceuticals, Inc.
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Broo...
Ophthalmic Drugs720 affectedMar 25, 2026
High RiskFDA
Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp.,...
Ophthalmic Drugs107,136 affectedMar 5, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED B...
Ophthalmic Drugs589,848 affectedMar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY ...
Ophthalmic Drugs245,184 affectedMar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed B...
Ophthalmic Drugs378,144 affectedMar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Dist...
Ophthalmic Drugs1,023,096 affectedMar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Dis...
Ophthalmic Drugs315,144 affectedMar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Steri...
Ophthalmic Drugs303,216 affectedMar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED B...
Ophthalmic Drugs182,424 affectedMar 3, 2026
High RiskFDA
K.c. Pharmaceuticals, Inc
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LU...
Ophthalmic Drugs74,016 affectedMar 3, 2026
High RiskFDA
Wizcure Pharmaa Private Limited
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-II...
Ophthalmic Drugs184,320 affectedDec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, ...
Ophthalmic Drugs50,400 affectedDec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl...
Ophthalmic Drugs5,760 affectedDec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt...
Ophthalmic Drugs139,104 affectedDec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa P...
Ophthalmic Drugs11,520 affectedDec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. ...
Ophthalmic Drugs10,080 affectedDec 31, 2025
RecallFDA
Imprimis Njof, Llc
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bo...
Ophthalmic Drugs67,091 affectedOct 20, 2025
High RiskFDA
Usv Private Limited
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rou...
Ophthalmic Drugs8,952 affectedOct 9, 2025
High RiskFDA
Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc....
Ophthalmic Drugs151,034 affectedSep 5, 2025
High RiskFDA
Apotex Corp.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L...
Ophthalmic Drugs493,468 affectedSep 5, 2025
RecallFDA
Imprimis Njof, Llc
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Im...
Ophthalmic Drugs2,890 affectedJul 9, 2025
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr...
Ophthalmic Drugs154,176 affectedJul 5, 2025
High RiskFDA
Apotex Corp.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufa...
Ophthalmic Drugs87,840 affectedMay 28, 2025
High RiskFDA
Apotex Corp.
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for...
Ophthalmic Drugs105,456 affectedMay 28, 2025
High RiskFDA
Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Onta...
Ophthalmic Drugs6,288 affectedMay 28, 2025
High RiskFDA
Alembic Pharmaceuticals Limited
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 079...
Ophthalmic Drugs0 affectedMay 7, 2025
High RiskFDA
Brs Analytical Services, Llc
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 F...
Ophthalmic Drugs13,872 affectedApr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed ...
Ophthalmic Drugs14,333 affectedApr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moist...
Ophthalmic Drugs13,104 affectedApr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturi...
Ophthalmic Drugs32,876 affectedApr 23, 2025
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharasht...
Ophthalmic Drugs60,428 affectedApr 18, 2025
High RiskFDA
Fdc Limited
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ....
Ophthalmic Drugs90,960 affectedMar 11, 2025
RecallFDA
Imprimis Njof, Llc
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Impri...
Ophthalmic Drugs2,822 affectedFeb 24, 2025
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr...
Ophthalmic Drugs118,104 affectedJan 23, 2025
RecallFDA
Avkare
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKAR...
Ophthalmic Drugs16,677 affectedDec 18, 2024
CriticalFDA
Alcon Research Llc
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Ophthalmic Drugs55,960 affectedDec 18, 2024
RecallFDA
Avkare
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, ...
Ophthalmic Drugs0 affectedDec 18, 2024
High RiskFDA
Fdc Limited
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairf...
Ophthalmic Drugs136,181 affectedDec 16, 2024
RecallFDA
Somerset Therapeutics Llc
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, ND...
Ophthalmic Drugs5,870 affectedDec 16, 2024
High RiskFDA
Regenerative Processing Plant, Llc
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerati...
Ophthalmic Drugs170,812 affectedDec 10, 2024
High RiskFDA
Regenerative Processing Plant, Llc
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: R...
Ophthalmic Drugs59,275 affectedDec 10, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharash...
Ophthalmic Drugs5,184 affectedDec 5, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr...
Ophthalmic Drugs155,232 affectedOct 29, 2024
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Ophthalmic Drugs27 affectedSep 11, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx o...
Ophthalmic Drugs176,784 affectedAug 12, 2024
High RiskFDA
Fdc Limited
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx On...
Ophthalmic Drugs66,528 affectedJul 23, 2024